BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFORM INTRAPERITONEAL MESH

    MDR report key: 24604380 · Received March 16, 2026

    Report

    Report Number
    MW5185226
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    December 10, 2024
    Report Date
    March 6, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    OWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INTRAPERITONEAL, (B)(6) 2024. HAVE NOT BEEN ABLE TO EAT ANY TYPE OF SOLID FOOD SINCE THAT SURGERY. SEVERE STRICTURE AT THE GE JUNCTION WHERE MESH WAS PLACED. 16 EGDS WITH DILATION AND AN ABORTED/FAILED REVISION SURGERY IN (B)(6) 2026, WHICH FOUND EXTENSIVE ADHESIONS, MAKING IT IMPOSSIBLE TO COMPLETE THE REVISION SURGERY. I NOW HAVE A GASTRIC FEEDING TUBE FOR NUTRITION. ALL BIOPSY REPORTS ON GASTRIC AND ESOPHAGEAL TISSUE NEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663343 ENFORM INTRAPERITONEAL MESH MESH, SURGICAL, ABSORBABLE, THORACIC, CHEST WALL RECONSTRUCTION OWZ W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| S ATORVASTATIN 20 MG QD.| MERTAZAPINE 15 MG QHS.| SERTRALINE 100 MG QHS.